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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial

Da Cruz, L; Dorn, JD; Humayun, MS; Dagnelie, G; Handa, J; Barale, P-O; Sahel, J-A; ... Greenberg, RJ; + view all (2016) Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology , 123 (10) pp. 2248-2254. 10.1016/j.ophtha.2016.06.049. Green open access

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Abstract

Purpose: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. / Design: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. / Participants: Thirty participants in 10 centers in the United States and Europe. / Methods: The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. / Main Outcome Measures: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. / Results: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. / Conclusions: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.

Type: Article
Title: Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ophtha.2016.06.049
Publisher version: http://dx.doi.org/10.1016/j.ophtha.2016.06.049
Language: English
Additional information: Copyright © 2016 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery.ucl.ac.uk/id/eprint/10054241
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